urinary catheter

Abstract

A method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material, the tube defining a tubular shape having an inner surface facing an internal discharge conduit and an opposite outer surface facing away from the internal discharge conduit; and providing a plurality of discharge openings extending between an inner opening in the inner surface and an outer opening in the outer surface by laser ablation of the base material, wherein the laser ablation is performed using a laser emitted from an emitter point outside the discharge conduit at a certain emission angle, such that a first set of discharge openings is provided with a first emission angle and a second set of discharge openings is provided with a second emission angle.

Description

[0001] This application is a divisional application of the invention patent application entitled "Urinary Catheter", with an international application date of February 7, 2020, international application number PCT / DK2020 / 050032, and national application number 202080012934.0. Technical Field

[0002] This disclosure relates to an intermittent hydrophilic urinary catheter, a method of using such a catheter, and a method of manufacturing such a catheter. Background Technology

[0003] Existing catheters have various problems, such as the drainage opening being blocked by bladder wall tissue, and the bladder not being completely emptied during catheter insertion. Summary of the Invention

[0004] The present invention provides a method for manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material, the tube defining a tubular shape having an inner surface facing an internal discharge conduit and an opposite outer surface facing away from the internal discharge conduit; and providing a plurality of discharge openings extending between an inner opening in the inner surface and an outer opening in the outer surface by laser ablation of the base material, wherein the laser ablation is performed using a laser emitted from an emitter point outside the discharge conduit at a certain emission angle, such that a first set of discharge openings is provided with a first emission angle and a second set of discharge openings is provided with a second emission angle. Attached Figure Description

[0005] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated in and are a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and many of the anticipated advantages of the embodiments will be readily appreciated as they will become better understood with reference to the following detailed description. Elements of the drawings are not necessarily to scale. The same reference numerals indicate corresponding similar parts.

[0006] Figures 1 to 4 This demonstrates the potential problems with existing intermittent urinary catheters.

[0007] Figure 5 An embodiment of an intermittent urinary catheter with multiple small discharge openings is shown; the catheter is shown in a projection view.

[0008] Figure 6 , Figure 7 , Figure 8 , Figure 9A and Figure 9B The functionality of an embodiment of an intermittent urinary catheter is demonstrated.

[0009] Figure 10 An enlarged view of a section of the conduit along the longitudinal direction indicated by the centerline CA is shown.

[0010] Figures 11 to 12 A further enlarged view of the exhaust opening 5 is shown.

[0011] Figures 13 to 14 It shows the protrusions surrounding the opening in the outer surface.

[0012] Figure 15 , Figure 16A and Figure 16B An example of an intermittent urinary catheter is shown.

[0013] Figures 17 to 19 The positioning of a laser emitter is shown according to an embodiment of a method for manufacturing a conduit.

[0014] Figures 20 to 22 The positioning of a laser emitter is shown according to an embodiment of a method for manufacturing a conduit.

[0015] Figures 23 to 25 The positioning of a laser emitter is shown according to an embodiment of a method for manufacturing a conduit.

[0016] Figures 26 to 28 The magnitude of the pressure pulses in the intermittent urinary catheter is shown.

[0017] Figure 29A , Figure 29B , Figure 30 and Figure 31 The pressure pulses vary with the size of the exhaust opening.

[0018] Figures 32 to 34 A testing device for determining pressure pulses in intermittent urinary catheters was demonstrated.

[0019] Figure 35 The flow velocity curve is shown as a function of the total inflow area. Detailed Implementation

[0020] This disclosure provides an intermittent hydrophilic catheter defining a discharge conduit extending longitudinally from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit. The catheter includes a tubular portion having a tubular wall made of a base material and defining an inner surface facing the discharge conduit and an opposite outer surface facing away from the discharge conduit. At least an insertable portion of the outer surface is covered by a layer of hydrophilic material configured to swell upon contact with a swelling medium. The hydrophilic material defines a hydrophilic surface of the catheter on the outer surface by a coating thickness. The catheter includes a plurality of discharge openings, each defined by a discharge opening wall extending between an inner opening in the inner surface and an outer opening in the outer surface. The discharge openings are formed by laser ablation of the hydrophilic material and the base material, such that the discharge opening walls are not covered by the hydrophilic material.

[0021] Since the discharge openings in these embodiments are created by laser ablation of a substrate material covered with a hydrophilic material, both the substrate material and the hydrophilic material are removed at the discharge opening. Therefore, no hydrophilic material residue remains on the walls of the discharge opening. In other words, the walls of the discharge opening are free of hydrophilic material. This has the effect that the discharge opening can be very small and will not be blocked by the hydrophilic material when it swells.

[0022] The embodiments disclosed herein provide an intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit. The catheter includes a plurality of discharge openings, each discharge opening extending along a central line from an internal opening into the discharge conduit to an external opening in an outer surface, wherein at least two discharge openings have a central line intersecting at a point on the outside of the discharge conduit.

[0023] These embodiments have the effect that fluid flow from a single point in the bladder can flow linearly into the discharge pipe through more than one discharge opening. This can potentially provide improved flow characteristics and also reduce the risk of blockage.

[0024] The embodiments disclosed herein provide an intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit. The catheter includes a plurality of discharge openings, each discharge opening extending along a corresponding central line from an inner surface toward the discharge conduit to an outer surface away from the discharge conduit. The discharge openings are formed in pairs, such that a pair of discharge openings includes a first discharge opening and a second discharge opening having the same central line.

[0025] The discharge openings are arranged on opposite sides of the central axis. This has the effect that if the first discharge opening, which is centered, is offset against the urinary catheter wall, the likelihood of the second discharge opening not contacting the other side of the urinary catheter increases, thus providing freer flow of urine into the discharge pipe.

[0026] This disclosure provides an intermittent hydrophilic catheter defining a discharge conduit extending longitudinally from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit. The catheter includes a tubular portion having a tubular wall made of a base material and defining an inner surface facing the discharge conduit and an outer surface facing away from the discharge conduit. At least an insertable portion of the outer surface is covered by a layer of hydrophilic material configured to swell upon contact with a swelling medium. The hydrophilic material defines a hydrophilic surface of the catheter at the outer surface with a coating thickness. The catheter includes a plurality of discharge openings extending between an internal opening in the inner surface and an external opening in the outer surface. The outer surface forms protrusions surrounding the external openings and extending above the hydrophilic surface when the hydrophilic material is in a non-swelling state.

[0027] These protrusions typically extend in the radial direction.

[0028] These embodiments have the effect that the risk of hydrophilic material being displaced to the location where it covers the discharge opening is further limited, as it must go over the protrusion.

[0029] During catheter insertion, tissue in the urethra may collapse into the drainage opening. Providing a protrusion around the drainage opening has the effect that the tissue is lifted over the drainage opening as the catheter moves through the urethra. Therefore, the protrusion reduces the risk of abrasion when the catheter slides along the tissue during insertion and removal.

[0030] The size of the protrusion and the thickness of the hydrophilic material layer can be selected so that the hydrophilic material extends over the protrusion when it swells. Because the hydrophilic material extends over the protrusion when it swells, the tissue is protected by the hydrophilic material during catheter insertion and removal, and the risk of abrasion from the protrusion is reduced.

[0031] The embodiments disclosed herein provide an intermittent catheter that significantly reduces the risk of impacting the bladder wall and urethral tissue during intermittent catheter insertion. Furthermore, the catheter insertion procedure for emptying the bladder is easier, eliminating the need for catheter repositioning, thereby increasing the likelihood of satisfactory bladder emptying with each catheter insertion.

[0032] During intermittent catheter insertion and bladder emptying, the bladder contracts and eventually the bladder wall approaches the catheter. The pressure difference between the bladder and the external environment causes urine to flow out of the bladder through the catheter. If all the discharge openings of an intermittent catheter are suddenly blocked by bladder wall tissue, a negative pressure pulse is generated in the catheter due to the sudden cessation of the moving column of urine in the catheter. This negative pressure abruptly draws tissue toward the discharge openings, and if the negative pressure remains constant, it may even be aspirated into the lumen of the catheter. In the context of this disclosure, this phenomenon will be referred to as blockage. Aspiration can affect bladder wall tissue. The magnitude of the negative pressure depends particularly on the suddenness of the blockage of the discharge openings and the flow rate. If the catheter is a prior art intermittent catheter, such as one that typically has two discharge openings, one of the discharge openings may be blocked by bladder wall tissue, which may only result in a limited negative pressure pulse. However, if the second and last discharge openings are also blocked by bladder wall tissue, the flow of urine through the catheter is suddenly interrupted, resulting in a significant negative pressure pulse in the catheter. This causes tissue near the discharge openings to be aspirated into the lumen of the catheter through the discharge openings. The negative pressure pulse that draws bladder tissue into the drainage opening may be the cause of the bladder pressure felt by some catheter users.

[0033] In contrast to these drawbacks of commonly available catheters, this disclosure provides an intermittent catheter that uses multiple discharge openings, which prevents the possibility of all discharge openings closing suddenly and almost simultaneously, thereby eliminating the occurrence of negative pressure pulses drawing bladder wall tissue toward and aspirating into the discharge openings. The multiple discharge openings described herein ensure that potential obstruction of the discharge openings occurs only gradually during urination when contact occurs between the bladder wall and the catheter. Furthermore, if the size of the discharge openings is small, there is a further advantage that when the last of all discharge openings is obstructed by bladder wall tissue upon achieving complete urination (no residual urine in the bladder), the small flow of urine through that last obstructed discharge opening is reduced to the level where the sudden closure of that last opening would only cause a small negative pressure pulse.

[0034] During the use of existing intermittent catheters, bladder wall tissue may obstruct the discharge opening, possibly due to the inflow drawing bladder wall tissue toward the discharge opening, as described above. As demonstrated in the tests described below and illustrated in the accompanying figures related to existing catheters, a significant amount of bladder wall tissue may enter the catheter lumen and become trapped in the discharge opening due to bladder tissue aspiration. This is conceivable because the negative pressure pulse causes the discharge opening to become blocked as described above, and once blocked, the pressure difference between the bladder wall and the lumen gradually deforms the bladder wall, allowing bladder wall tissue to enter the discharge opening. If the blockage of the discharge opening significantly or completely reduces urine flow, the user may attempt to move the catheter up or down or rotate the catheter to reposition the discharge opening and restore flow. The user may also withdraw the catheter when they believe that the bladder is empty because urine flow has stopped. The risk of bladder wall tissue being affected by catheter movement can be reduced by preventing bladder wall tissue from being trapped in the discharge opening.

[0035] As described above, contact between the bladder wall and the discharge opening of a prior art catheter can cause bladder wall tissue to obstruct the discharge opening, thereby reducing or completely stopping urine flow. Inappropriate obstruction of the discharge opening of an intermittent catheter may cause the user to withdraw the catheter believing that the bladder is empty because flow has stopped or significantly decreased. If the catheter user prematurely abandons the urination procedure for this reason, residual urine may remain in the bladder. The intermittent catheter with multiple small discharge openings according to this disclosure prevents premature obstruction of the discharge openings, thereby ensuring urine flow until the bladder is empty. Therefore, the intermittent catheter with multiple discharge openings as disclosed herein ensures that the catheter user does not mistakenly believe the bladder is empty and thus prematurely terminate the urination process, resulting in residual urine remaining in the bladder.

[0036] In the following text, whenever the proximal end of an element disclosed herein is referred to, it means the end adapted for insertion. Whenever the distal end of an element is referred to, it means the end opposite to the insertion end. In other words, the proximal end is the end closest to the user when the catheter is to be inserted, while the distal end is the opposite end, that is, the end furthest from the user when the catheter is to be inserted.

[0037] The longitudinal direction is from distal to proximal. The transverse direction is perpendicular to the longitudinal direction, corresponding to the direction that crosses the duct.

[0038] The intermittent urinary catheter according to this disclosure includes a tubular portion extending from a proximal insertion end to a distal outlet end proximally. The tubular portion may be cylindrical or conical. In an embodiment, the tubular portion has an elliptical cross-section. The tubular portion is configured to provide urine flow from the discharge portion to the distal end through the intermittent catheter. A closed-end portion having a closed tip is positioned proximally in the catheter and is configured as a circular closed end of the tube constituting the tubular portion of the catheter. The discharge portion of the tubular portion is typically located in the proximal portion of the tubular portion. In an embodiment, the discharge portion includes a plurality of discharge openings to provide flow of urine between the exterior of the catheter and the interior of the tubular portion. In an embodiment, the discharge portion is longer than a typical flow area on a prior art catheter, wherein the flow area is defined as the length from the distal edge of the distal orifice to the proximal edge of the proximal orifice. In an embodiment, the intermittent catheter includes a connector at the distal end. In an embodiment, the connector includes a flared end of the catheter such that the diameter of the connector is increased relative to the tubular portion. In one embodiment, the intermittent catheter includes a handle at the distal end, the handle having a length that allows the user to manipulate the catheter.

[0039] Intermittent catheters are typically available in sizes 8FR to 18FR. FR (or French size or Charriere (Ch)) is the standard gauge for catheters, roughly corresponding to the outer circumference (in mm). More precisely, the outer diameter of the catheter (in mm) corresponds to FR divided by 3. Therefore, 8FR corresponds to a catheter with an outer diameter of 2.7 mm and 18FR corresponds to a catheter with an outer diameter of 6 mm.

[0040] A hydrophilic coating may be provided only on the insertable portion of the catheter. A hydrophilic surface coating is a type of surface coating that reduces friction on the catheter surface area intended for insertion into the user's lower urinary tract corresponding to the insertable portion of the catheter when hydrated or swollen using a swelling medium.

[0041] The difference between intermittent hydrophilic catheters and indwelling catheters is that the hydrophilic surface coating of such catheters is not suitable for indwelling use because if left in the body for more than 5-20 minutes, the surface coating is prone to sticking to the urethral mucosa. This is because the hydrophilic coating changes from being highly smooth when fully wetted (95% water by weight) to becoming sticky when the hydration level of the coating decreases (<75% water by weight).

[0042] The catheter may have a closed end at the proximal insertion end, and specifically, it may have multiple discharge openings distributed on a portion of the catheter located near the closed end, for example, constituting half or one-third of the entire length of the catheter measured from proximal to distal.

[0043] The emission openings described herein are sometimes referred to in the art as orifices or eyes. These emission openings have a closed-loop circumference and can be circular, elliptical, square, triangular, and any other closed-loop shape. This closed-loop shape defines the outer opening of the emission opening. The inner opening of the emission opening will also have a closed-loop circumference and will typically (but not necessarily) have the same shape as the outer opening of the emission opening.

[0044] The catheter may have at least 12 discharge openings, and the discharge openings may be specifically arranged in one or more groups, for example, in a straight line extending in the longitudinal direction. The discharge openings may also be arranged in groups such that the density of discharge openings differs between groups.

[0045] Each discharge opening may be defined by a wall extending from an internal opening in the inner surface facing the discharge conduit to an external opening in the outer surface facing away from the discharge conduit. Therefore, the discharge opening wall may have a height corresponding to the distance between the inner and outer surfaces of the tubular portion of the conduit. Specifically, the discharge opening wall may extend continuously between the inner and outer surfaces. The internal opening may also be referred to as an outlet opening and the external opening may also be referred to as an inlet opening.

[0046] The tubular wall of the tube can have a uniform wall thickness, thus providing a uniform length of discharge opening.

[0047] The tubular portion has a uniform outer surface, enabling uniform bonding with hydrophilic materials. Furthermore, the risk of hydrophilic material displacement and thus potential blockage of the discharge opening is minimized.

[0048] The embodiments relate to a catheter with a closed tip at the proximal insertion end. This closed tip may be configured as a Nelaton tip, a flexible tip, or a tip of a known type commonly used for urinary catheters.

[0049] In the context of this disclosure, body cavity refers to the urethra.

[0050] The conduit may be defined as a non-discharge portion distal to the tip and a discharge portion distal to the non-discharge portion, the discharge portion being provided with the plurality of discharge openings. The non-discharge portion may be, for example, less than 3 cm, less than 2 cm, or less than 1 cm, and the discharge portion may be less than 20 cm, less than 15 cm, or less than 10 cm.

[0051] The inflow of urine through multiple discharge openings depends on the sum of the cross-sectional areas of all the discharge openings (total inflow area) and the pressure gradient between the discharge opening and the distal catheter exit, as explained above. The sum of the cross-sectional areas of the multiple discharge openings (total inflow area) must be large enough to provide sufficient urine inflow; otherwise, emptying the bladder would take a long time and thus be inconvenient for users of intermittent catheters. Each discharge opening provides a certain resistance to the inflow of urine, which depends particularly on the cross-sectional area of ​​the discharge opening and the thickness of the catheter material at the discharge opening, i.e., the extent of the discharge opening wall from the inner opening to the outer opening.

[0052] The embodiment involves a total cross-sectional area of ​​multiple discharge openings that is greater than the cross-sectional area of ​​the discharge pipe of the conduit located distal to the discharge opening. "Distal to the discharge opening" means within 5 mm of the farthest discharge opening in the longitudinal direction.

[0053] The embodiment relates to a tubular portion defining a convex outer surface, wherein the total inflow area of ​​the discharge openings in the convex outer surface of the tubular portion is greater than the cross-sectional area of ​​the discharge conduit in a section perpendicular to the longitudinal direction of the tubular portion at a location distal to the discharge openings.

[0054] In this embodiment, the sum of the cross-sectional areas of the plurality of discharge openings (total inflow area) is greater than twice the cross-sectional area of ​​the conduit lumen just distal to the discharge openings. The total inflow area of ​​the discharge openings is disposed within the convex outer surface of the tubular portion. Providing such a large total inflow area ensures that flow resistance at the discharge openings will not impede the filling of the conduit's discharge channel. Therefore, the inflow rate into the discharge channel through the discharge openings does not restrict the flow rate through the intermittent conduit.

[0055] A further embodiment involves the sum of the cross-sectional areas of multiple discharge openings (total inflow area) being at least three times larger than the cross-sectional area of ​​the discharge pipe of the duct.

[0056] Embodiments where the total inflow area in the convex outer surface of the tubular portion is at least equal to or greater than the cross-sectional area of ​​the discharge pipe of the tubular portion can relate to a conduit having a cylindrical tubular portion. In this case, the cross-sectional area of ​​the discharge pipe is constant over the entire length of the conduit. However, these embodiments can also relate to a conduit having a conical tubular portion. In this case, the cross-sectional area increases along the length. In this case, the total inflow area should be compared with the cross-sectional area of ​​the discharge pipe at the distal end of the farthest discharge opening (i.e., within 5 mm in the distal direction of the farthest discharge opening).

[0057] The embodiments involve a number of discharge openings greater than the number required to fill the discharge conduit just distal to said discharge openings. It should be understood that, depending on the size of each discharge opening, a certain number of discharge openings are required to provide a total inflow area corresponding to the cross-sectional area of ​​the discharge conduit distal to the discharge openings. In this disclosure, this number of discharge openings is referred to as a first predetermined number of discharge openings. Therefore, the embodiments involve a number of discharge openings greater than the first predetermined number of discharge openings.

[0058] The embodiment relates to an intermittent urinary catheter as defined above and provided with a plurality of discharge openings, the discharge openings being configured to provide a total inflow area exceeding the cross-sectional area of ​​the discharge conduit in the catheter at the distal end of the discharge opening.

[0059] When the total inflow area exceeds the cross-sectional area of ​​the catheter's discharge channel, or the number of discharge openings exceeds the number required to fill the discharge channel, at least one discharge opening is always available to provide inflow. This is because the inflow rate is less than the flow rate that the discharge opening can discharge—therefore, if another discharge opening is simultaneously blocked by bladder tissue, at least one discharge opening will be able to provide further inflow. This means that flow through the catheter will continue until the bladder is empty. Therefore, the risk of leaving residual urine in the bladder is greatly reduced.

[0060] In the context of this disclosure, pressure refers to partial pressure, not absolute pressure. This means that pressure is always indicated as the pressure difference between the measurement point and the ambient pressure.

[0061] In an embodiment, the maximum size of a single discharge opening in the convex outer surface of the tubular portion is less than 1 mm. Maximum size refers to the diameter in the case of a circular discharge opening, the main axis in the case of an elliptical opening, the diagonal in the case of a rectangular or square opening, etc. In other words, maximum size refers to the maximum size of the span of the opening between two relatively positioned points on the periphery of the opening on the convex outer surface of the tubular portion. In a related embodiment, each discharge opening has a size of less than 0.8 mm. 2 The cross-sectional area.

[0062] Therefore, it ensures that the negative pressure that may occur when measuring at 10 cm H2O is no greater than 50 mBar, thus significantly reducing the impact on bladder wall tissue compared to existing catheters with a small number (such as two) of large drainage openings.

[0063] In one embodiment, the maximum size of any individual discharge opening on the convex outer surface of the tubular portion is less than 0.7 mm. In a related embodiment, the cross-sectional area of ​​each individual discharge opening is less than 0.4 mm². 2 Therefore, it was ensured that the negative pressure could not exceed 40 mBar when measuring at 10 cm H2O.

[0064] In one embodiment, the maximum size of any individual discharge opening on the convex outer surface of the tubular portion is less than 0.5 mm. In a related embodiment, the cross-sectional area of ​​each individual discharge opening is less than 0.2 mm². 2 .

[0065] In this embodiment, the number of discharge openings exceeds 20.

[0066] Therefore, the possibility of all emission openings being blocked simultaneously is significantly reduced.

[0067] In embodiments, the number of emission openings can be significantly higher, for example, more than 200 or even about 260 emission openings. This number can also be around 100, 120 or 150, or close to 200, such as 180.

[0068] The embodiment relates to an intermittent urinary catheter, wherein the catheter is CH10, each discharge opening has a maximum dimension of about 0.4 mm in the convex outer surface of the tubular portion, and the number of discharge openings is greater than 32. Such a catheter provides sufficient inflow into the catheter lumen such that each discharge opening facilitates drainage, but at least one discharge opening remains open at all times. About 0.4 mm means between 0.35 and 0.45 mm.

[0069] Other embodiments relate to an intermittent urinary catheter, wherein the catheter is CH12, each discharge opening has a maximum dimension of approximately 0.7 mm in the convex outer surface of the tubular portion, and the number of discharge openings is greater than 15. Approximately 0.7 mm means between 0.65 mm and 0.75 mm.

[0070] The embodiments relate to an intermittent urinary catheter as described in any of the preceding claims, wherein each of the discharge openings extends transversely to the longitudinal direction of the catheter. Transverse extension means that the central axis of the discharge opening is substantially perpendicular to the longitudinal axis of the catheter, i.e., within 20 degrees in any direction.

[0071] In this embodiment, the discharge portion is 4 cm long in the longitudinal direction of the intermittent catheter. This provides good bladder emptying. The discharge portion is located distal to the closed end portion, so that if the closed end portion is less than 2 cm in the longitudinal direction, the discharge portion is within 6 cm of the nearest side of the catheter. This is a common insertion length for intermittent catheters in the bladder—therefore, positioning the discharge portion within the bladder provides a large cross-sectional area for multiple discharge openings to be located within the bladder, thus providing good and rapid bladder emptying. An approximately 4 cm discharge portion can be used for both male and female catheters. Approximately 4 cm means between 35 mm and 45 mm, such as 40 mm, 37 mm, or 42 mm.

[0072] In one embodiment, the discharge portion is 10 cm long in the longitudinal direction of the intermittent catheter. This provides enhanced safety for bladder emptying because the discharge opening is located at the lower part of the bladder, at the bladder neck. Typically, the intermittent catheter is inserted 5-6 cm into the bladder, so in these embodiments, the discharge portion extends into a portion of the urethra and is located within the bladder. Catheters with a discharge portion of 10 cm or more are particularly useful for male catheters. Other embodiments involve a discharge portion length of approximately 8 cm, i.e., between 75 mm and 85 mm, such as 77 mm, 80 mm, or 82 mm.

[0073] In this embodiment, the discharge portion is 15 cm long in the longitudinal direction of the intermittent catheter. This provides enhanced safety for emptying the bladder. This is particularly beneficial for users who tend to insert their intermittent catheters too deeply into their bladder (perhaps because they do not feel anything during catheter insertion).

[0074] The embodiment involves a discharge portion with a length of approximately 2 cm, that is, between 15 mm and 25 mm. This short discharge portion is particularly useful for female catheters with relatively short urethras. The short discharge portion reduces the risk of urine leakage through the discharge opening, in case some discharge openings are located outside the urethra.

[0075] In one embodiment, the discharge openings are positioned in a dispersed manner along the longitudinal direction and around the circumference of the conduit.

[0076] In one embodiment, the discharge openings are positioned in four longitudinal rows, with 90 degrees between them around the circumference.

[0077] In one embodiment, the discharge openings are positioned in six longitudinal rows, with 60 degrees between them around the circumference.

[0078] In one embodiment, the discharge openings are positioned in eight longitudinal rows, with 45 degrees between them around the circumference.

[0079] In one embodiment, the discharge opening is positioned in two longitudinal rows, with 180 degrees between them around the circumference.

[0080] In one embodiment, the discharge opening is positioned in two pairs of parallel rows, with 180 degrees between the rows around the circumference.

[0081] In one embodiment, the discharge opening is spirally dispersed around the circumference.

[0082] The increased number of directions provides better inflow and reduces the risk of bladder tissue obstruction from contacting all discharge openings.

[0083] In one embodiment, the tip portion of the catheter is a nelaton tip, wherein the proximal end is simply closed to provide a hemispherical closed end.

[0084] The end portion can be integrally formed with the main tube portion (or formed as one or two parts), or it can be provided as a separate element and then attached to the main tube portion, for example, by welding or adhesion.

[0085] In one embodiment, the tip portion is a flexible tip. In this type of embodiment, starting from the distal end of the tip portion, the tip of the catheter includes: a discharge portion having a discharge opening for allowing urine to enter the inner lumen of the catheter; a middle portion, wherein the diameter of the catheter decreases relative to the diameter of the rest of the catheter; and a proximal portion having a spherical shape with a diameter close to or exceeding that of the tubular portion of the catheter. The spherical shape may also have a diameter slightly smaller than that of the tubular portion of the catheter. The shape of the spherical shape may be nearly spherical, or it may be slightly elongated and shaped like an olive or a teardrop. This type of tip portion can be useful for male users to guide the catheter through a bend in the urethra around the prostate.

[0086] The base material can be polyurethane (PU), polyvinyl chloride (PVC), or polyolefins such as polyethylene (PE). Other materials can be silicone resins, latex, styrene block copolymers, TPS (TPE-s) (thermoplastic elastomers), thermoplastic vulcanizates, TPV, thermoplastic copolyesters, TPC (TPE-E), thermoplastic polyamides, and TPA (TPE-A). The base material can also be referred to as the base material. The hydrophilic material can be polyvinylpyrrolidone (PVP) and copolymers.

[0087] The emission openings can be formed in pairs, such that a pair of emission openings includes a first emission opening and a second emission opening having the same centerline.

[0088] The embodiments involve positioning the exhaust openings at an angle relative to the longitudinal axis. The embodiments also involve positioning the exhaust openings at an angle between 80 and 87 degrees relative to the longitudinal axis, such as an angle between 85 and 87 degrees.

[0089] The discharge opening can be shaped such that the walls of the first discharge opening converge in the direction from the outer opening to the inner opening, and the walls of the second discharge opening diverge in the direction from the outer opening to the inner opening.

[0090] Convergence in this context refers to the distance between the wall portions on opposite sides of the centerline decreasing in the direction from the outer surface to the inner surface. In other words, the area of ​​the outer opening is larger than that of the inner opening. Divergence in this context refers to the distance between the wall portions on opposite sides of the centerline increasing in the direction from the outer surface to the inner surface. In other words, the area of ​​the outer opening is smaller than that of the inner opening.

[0091] If the exhaust opening is circular, the exhaust opening wall can have a truncated cone shape. In this paper, this shape is referred to as truncated cone to indicate that the cross-section of the exhaust opening does not have to be circular.

[0092] The converging and diverging walls of the discharge openings provide different flow characteristics through the first and second discharge openings, and increase the likelihood that the other discharge opening will remain open if one of the two discharge openings is blocked. The specific shape of these converging and diverging walls results in an outer opening on the outer surface being larger than an inner opening on the inner surface for one of the discharge openings, and vice versa for the other of the pair of discharge openings. Therefore, preventing tissue from contacting the relatively larger opening may not prevent flow through the relatively smaller opening, and vice versa.

[0093] The first and second exhaust openings can have different dimensions. That is, the dimensions of the first exhaust opening in a cross section transverse to the centerline can differ from the dimensions of the second exhaust opening, especially when comparing dimensions in cross sections at the same distance from the inner and outer surfaces.

[0094] The coating thickness can be reduced towards each inlet opening on the outer surface, thereby decreasing the risk of blockage of flow through the inlet openings when the hydrophilic material swells. This means that the coating is thicker in the region between the discharge openings than in the region closer to the discharge opening. "Closer to the discharge opening" refers to a distance of 0.5 mm from the edge of the discharge opening.

[0095] The tubular portion has a uniform outer surface, which enables uniform bonding with hydrophilic materials and further avoids displacement of the hydrophilic materials and potential blockage of the discharge opening.

[0096] This disclosure provides a manufacturing method. For example, laser ablation can be performed using a CO2 laser.

[0097] This disclosure provides a method for manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube, for example, by extruding a base material via a die defining a tubular shape having an inner surface facing a discharge conduit and an opposite outer surface facing away from the discharge conduit; coating the outer surface with a hydrophilic material to define a hydrophilic surface; and providing a plurality of discharge openings from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that the walls of the discharge openings extending between the inner and outer surfaces are not coated. Therefore, laser ablation is used not only to create the discharge openings but also to remove the hydrophilic material, thereby reducing the risk of the hydrophilic material clogging the discharge openings.

[0098] This disclosure further provides a method for manufacturing a hydrophilic urinary catheter. According to this method, a tube is provided by extruding a base material via a die defining a tubular shape having an inner surface facing a discharge conduit and an opposite outer surface facing away from the discharge conduit. The outer surface is coated with a hydrophilic material to define a hydrophilic surface, and subsequently, i.e., after coating the outer surface, a plurality of discharge openings are provided from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that the walls of the discharge openings extending between the inner and outer surfaces are not coated.

[0099] This process avoids the use of hydrophilic materials in the discharge opening without increasing manufacturing complexity, thus providing a simple way to produce conduits with improved quality without potentially increasing manufacturing costs.

[0100] The embodiment relates to a method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a tubular shape having an inner surface facing an internal discharge conduit and an opposite outer surface facing away from the internal discharge conduit; and providing a plurality of discharge openings extending between an inner opening in the inner surface and an outer opening in the outer surface by laser ablation of the base material, wherein the laser ablation is performed using a laser emitted from an emitter point outside the discharge conduit at a certain emission angle, such that a first set of discharge openings is provided with a first emission angle and a second set of discharge openings is provided with a second emission angle.

[0101] This method can provide an efficient manufacturing approach that allows multiple emission openings to be created from a single, identical origin (e.g., by laser ablation from a single emission point).

[0102] The emission openings can be configured in pairs, one from a first set of emission openings and one from a second set of emission openings, wherein the emitter point moves relative to the tubular portion between each pair of emission openings.

[0103] When providing an emission opening, the distance from the emitter point to the outer surface can be kept constant.

[0104] The discharge opening can be provided through ablation, while the pressure in the discharge pipe changes relative to the pressure outside the discharge pipe.

[0105] The embodiment relates to a method of manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube made of a base material and defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit; and providing a plurality of discharge openings extending between an internal opening in an inner surface facing the discharge conduit and an external opening in an outer surface facing away from the discharge conduit, the discharge openings being formed by laser ablation of the base material, wherein the laser ablation is performed to form a pair of discharge openings including a first discharge opening and a second discharge opening, provided by simultaneously ablating the base material along a common centerline on opposite sides of the central axis.

[0106] Specifically, the laser can be emitted from an emitter point outside the exhaust duct, passing through the internal exhaust duct. The distance between the emitter point and the outer surface can correspond to at least 10 times the distance from the outer surface to the central axis, or at least 15 or 20 times the distance from the outer surface to the central axis.

[0107] The discharge opening can be provided through ablation, while the pressure in the discharge pipe changes relative to the pressure outside the discharge pipe.

[0108] The laser can be emitted with at least two subsequent pulses, such as three, four, five, six or more subsequent pulses. Specifically, the pulses can be emitted at frequencies higher than 1 Hz, such as higher than 2 Hz, 3 Hz, 4 Hz, 5 Hz, 6 Hz or even higher Hz.

[0109] The method may include determining an aperture size for at least one of a first emission opening and a second emission opening. In this way, laser ablation can be performed with a number of firings determined by the aperture size. In one embodiment, a limit size is defined, and the number of firings is increased until the limit size of at least one of the first and second emission openings is reached. In another embodiment, limit sizes are defined for both the first and second emission openings, and the number of firings is increased until both emission openings have the desired size.

[0110] In this article, the terminology is:

[0111] "Continuous" is defined as a surface that extends continuously without sharp edges or corners or similar obvious geometric changes, and is defined as having a radius of curvature of less than 3 mm.

[0112] A "uniform outer surface" is defined as an outer surface that has the same surface texture, color, and / or roughness or smoothness, except for continuous surfaces.

[0113] "Intermittent" defines the catheter as not intended for indwelling use, and it does not include balloons or other devices used to fix it in the bladder.

[0114] "Hydrophilicity" defines a material as swelling to such an extent that the resulting hydrogel reduces surface friction and facilitates easier insertion of the proximal end into the user's body cavity.

[0115] Example

[0116] The first test was performed to compare the pressure pulse levels between existing technology catheters and catheters with small discharge openings having a maximum size of less than 1.2 mm. The purpose of these first tests was to simulate a situation where one discharge opening is blocked by bladder tissue, and a second (last) discharge opening is suddenly blocked. A catheter with a small discharge opening (maximum size less than 1.2 mm) was used and compared to a standard existing technology catheter with two standard-sized discharge openings. In the latter case, one discharge opening was blocked with tape before the test. In all tests, the catheter was submerged in a tank and discharge was initiated. The testing setup was... Figures 32 to 34 As shown in the diagram and mentioned below, a pressure pulse in the lumen of the catheter is determined at the moment the second discharge opening is blocked. This corresponds to the situation during catheter insertion where the first discharge opening of the two discharge openings in a prior art catheter is blocked by bladder or urethral tissue, and the second discharge opening of the two discharge openings is suddenly blocked by tissue through suction of the catheter (caused by the flow of fluid).

[0117] The equipment used for testing is listed here:

[0118] Water tank with perforations and O-rings

[0119] 25L of water

[0120] • A conduit with one open discharge opening. If the conduit has two discharge openings, one discharge opening will be blocked during testing.

[0121] Waterproof pressure sensor attached to the needle tip

[0122] A 5x5cm piece of pig bladder

[0123] Latex gloves

[0124] Test according to the following test protocol:

[0125] • Provides a water tank including a seal adapted to provide a liquid-tight seal around the circumference of the conduit.

[0126] Insert the end of the conduit through the liquid-tight seal into the water tank until an open drain opening is completely inside the tank.

[0127] Let the water start flowing out through the pipe.

[0128] Gently tap the catheter to ensure there are no air bubbles inside.

[0129] Insert the sensor needle into the lumen of the catheter, approximately 1 cm from an open discharge opening.

[0130] • Ensure there are no air bubbles in the catheter or needle. This is important because even small air bubbles can obscure pressure readings.

[0131] • When there are no air bubbles in the cannula or needle, adjust the cannula's position in the water to an immersion depth of 10 cm, which means an open drain opening is approximately 10 cm below the water surface.

[0132] • The pipe section is positioned outside the water tank, so that the height difference between an open discharge opening and the pipe connector is about 15-20cm.

[0133] • Wear latex gloves and remove pig bladder tissue.

[0134] • Immerse the tissue in water

[0135] • Begin pressure recording and ensure the sensor is balanced, i.e., set to zero.

[0136] Slowly guide the pig bladder tissue toward an open discharge opening.

[0137] • When pig bladder tissue encounters an open discharge opening, a large (negative) pressure fluctuation occurs within the lumen of the catheter.

[0138] Note the magnitude of this pressure fluctuation.

[0139] The labeled pressure fluctuation corresponds to a pressure pulse within the catheter lumen. It will be labeled as a (negative) peak on the pressure curve—see [link to pressure curve]. Figure 26-28 Examples are shown in the text.

[0140] Some test results are shown in Table 1 below:

[0141] Table 1

[0142] ID Maximum size (mm) Suction pressure (mBar) 1.1 0.20 -1 1.2 0.46 -8 1.3 0.55 -15 1.4 0.65 -15 1.5 0.97 -44 1.6 3.90 -200

[0143] As can be seen from the table above, when the maximum size of the discharge opening is less than 1 mm (ID 1.1-1.5), the suction pressure is significantly reduced compared to the prior art catheter with a maximum discharge opening size of 3.9 mm (ID 1.6). All embodiments of the catheters according to this disclosure in ID 1.1 to 1.5 of Table 1 have suction pressures below 50 mBar (below 44 mBar), while the prior art catheter in ID 1.6 with a maximum discharge opening size of 3.9 mm has a suction pressure of 200 mBar. Therefore, as described above in Example 1, when tested at 10 cm H2O, the threshold for suction pressure in the lumen of the intermittent catheter according to this disclosure can be set to 50 mBar.

[0144] The test results are also available. Figure 26 , Figure 29A , Figure 29B It is displayed in the middle.

[0145] Before emptying, the pressure inside a normally functioning bladder can reach approximately 400-500 mBar (40-50 cmH2O).

[0146] The second and third tests were conducted in a similar manner, the only difference being that the catheter was submerged in 50 cm of H2O instead of 10 cm. In addition, male and female catheters were tested. The male catheter was tested with a height difference of 25 cm between the discharge opening and the outlet (connector), and the female catheter was tested with a height difference of 6 cm between the discharge opening and the outlet (connector).

[0147] The results are shown in Tables 2 and 3 below:

[0148] Table 2

[0149]

[0150]

[0151] Table 3

[0152] ID Maximum size (mm) Suction pressure (mBar) 1.15 0.19 -12 1.16 0.32 -48 1.17 0.40 -72 1.18 0.51 -100 1.19 0.60 -128 1.20 0.87 -233 1.21 0.99 -304 1.22 4.00 -639

[0153] The result is still pending. Figure 27 , Figure 28 , Figure 30 and Figure 31 As shown in the figure. Male catheters were tested with IDs 1.7–1.14, and female catheters were tested with IDs 1.15–1.22.

[0154] The catheters tested as IDs 1.7-1.13 and 1.15-1.21 were manufactured by Coloplast A / S under the trademark name [Brand Name Missing]. The catheter is a polyurethane catheter, while the prior art catheters tested (ID 1.14 and ID 1.22) are trademarked by Hollister Inc. PVC grade catheters. All types of catheters are size CH12. In the catheters (ID 1.7-1.13 and ID 1.15-1.22), only one discharge opening was made by laser cutting, and in the catheters of ID 1.14 and ID 1.22, as described above, one of the two existing discharge openings was blocked before testing.

[0155] The above is preferred if the aspiration pressure is consistently lower than the pressure achieved within the normally functioning bladder. Specifically, an aspiration pressure approximately half that of prior art catheters is an improvement. Therefore, embodiments relate to an intermittent catheter having a discharge opening and configured to provide a pressure pulse below a threshold of 350 mBar when performing the test described in Example 1, wherein the immersion depth is modified to be 50 cm and the height difference between the discharge opening and the outlet is 25 cm. Further embodiments relate to an intermittent catheter having a discharge opening and configured to provide a pressure pulse below a threshold of 300 mBar when performing the test described in Example 1, wherein the immersion depth is modified to be 50 cm and the height difference between the discharge opening and the outlet is 6 cm. Related embodiments relate to an intermittent catheter having a discharge opening and configured to provide a pressure pulse below a threshold of 200 mBar. Related embodiments relate to an intermittent catheter having a discharge opening and configured to provide a pressure pulse below a threshold of 100 mBar.

[0156] Another test was performed to evaluate the number of discharge openings required to provide the optimal flow rate through the intermittent catheters according to this disclosure. In this test, 108 prototype catheters were fabricated, and the flow rate through each catheter was determined. The 108 catheters were manufactured using three CH sizes: CH10, CH12, and CH16. The catheters were provided with discharge openings of three sizes: 0.4 mm, 0.6 mm, and 0.8 mm in diameter. The number of discharge openings varied between 15 and 240, and between 3 and 6 rows if the discharge openings were arranged in rows.

[0157] The results are shown in Table 4 below. Figure 35 It is displayed in the middle.

[0158] Table 4

[0159]

[0160] The results show that when the sum of the cross-sectional areas of the discharge openings (total inflow area) reaches the level of the cross-sectional area of ​​the duct lumen, the flow velocity through the duct will not increase further. In other words, when the total inflow area reaches the level of the lumen's cross-sectional area, the flow will converge.

[0161] Detailed description of the attached figures

[0162] Unless otherwise specifically stated, the features of the embodiments described in this application and the various exemplary embodiments may be combined with each other (“mixed and matched”).

[0163] Figures 1 to 4 It demonstrates various problems with existing conduits. Figure 1 A portion of a prior art catheter 100 inserted into the bladder 10 is shown. This catheter has two discharge openings 101 and 102. During catheter insertion, one discharge opening 101 may be blocked by bladder wall tissue, as shown, and then all urine from the bladder is drained through the second discharge opening 102. This situation creates a high suction effect through the second discharge opening 102, which may cause bladder wall tissue to come into contact with the second discharge opening 102, as described above. Figure 2 A portion of a prior art catheter 100 located in bladder 10 is shown. This figure illustrates a situation where the prior art catheter is positioned too high in bladder 10, above the bladder neck 11, so bladder 10 will not be completely emptied during catheter insertion. Residual urine in the bladder may lead to urinary tract infections. Figure 3 The diagram illustrates how the existing catheter 100 must then be moved up and down in an attempt to reduce the accumulation of residual urine. However, this up and down movement of the catheter may lead to… Figure 4 As shown, urethral tissue 21 from the bladder 10 or upper urethra 20 enters the discharge opening and is thus abraded during the upward and downward movement of the catheter.

[0164] Figure 5 An intermittent urinary catheter 1 as described herein is shown. The catheter forms a discharge tube extending longitudinally from the proximal insertion end to the distal outlet end. A tip 2 is provided at the proximal end of the catheter. Figure 5 In the image, the end is shown as the Nelaton end, but other end tips can be used. End tip 2 facilitates insertion into the bladder.

[0165] The catheter is further provided with a connector 3 at its distal end. The connector is configured to discharge urine from a discharge pipe, for example, into an extension tube, a collection bag, or a toilet.

[0166] The discharge opening 5 is located within the discharge section 4. In this embodiment, the discharge openings 5 ​​are positioned in four rows, paired, with these pairs spaced 180 degrees apart. Only two rows on one side of the intermittent catheter are visible in this figure.

[0167] This catheter is intended for intermittent catheter insertion and does not contain an inflatable balloon or similar device for long-term fixation in the bladder.

[0168] Figure 6 and Figure 7 An intermittent urinary catheter 1, as described herein, is shown, positioned such that the discharge portion extends into the bladder 10. In this embodiment, the tip 2 is a flexible tip. Figure 6 In the middle, the discharge openings 5 ​​are dispersedly located on the surface of the duct. Figure 6 This demonstrates how multiple drainage openings allow urine to flow in at multiple locations. Furthermore, having so many drainage openings reduces the likelihood of aspirating bladder tissue into a single drainage opening during catheter insertion, as described above. Figure 7 This demonstrates how the bladder 10 can be completely emptied by having so many discharge openings 5. This is because the possibility of all discharge openings being blocked is very small; therefore, urine will continue to flow until the bladder 10 is completely empty. Furthermore, the discharge portion 4 is relatively long, thus allowing the presence of discharge openings 5 ​​at the bladder neck 11, which helps ensure that the bladder 10 is emptied.

[0169] Figure 8 A portion of an embodiment of an intermittent catheter 1 positioned in the upper part of the urethra 20 as described herein is shown. The figure illustrates how urethral tissue 21 will not enter through the discharge opening 5, thereby reducing the risk of affecting the urethral tissue 20.

[0170] Figure 9A and Figure 9B This demonstrates that the discharge portion 4 of the catheter, as described herein, can be so long that even when the catheter is inserted until the tip 2 is at the top of the bladder ( Figure 9B The furthest side of the discharge opening 5 is still located below the bladder neck, that is, in the urethra.

[0171] Figure 10 An enlarged view of a section of the conduit along the longitudinal direction indicated by the central axis CA is shown. In this view, the conduit 1 is schematically shown to include a tubular portion 1a made of a base material and defining an inner surface 6 facing the discharge conduit 7 and an opposite outer surface 8 facing away from the discharge conduit, the outer surface extending continuously from the proximal insertion end to the distal outlet.

[0172] The portion of the outer surface intended for insertion into the body is covered by a layer 1b of hydrophilic material forming the hydrophilic surface 9 of the conduit. The coating thickness Y defines the radial extent of the coating at the outer surface 8.

[0173] Figure 11 A further enlarged view of the discharge opening 5 is shown. Each discharge opening 5 is defined by a discharge opening wall 5a extending between an inner opening 5b in the inner surface and an outer opening 5c ​​in the outer surface. In the illustrated embodiment, the outer opening 5c ​​is larger than the inner opening, such that the discharge opening wall converges from the outer surface to the inner surface.

[0174] Since the discharge opening is made by laser ablation after the hydrophilic material is deposited on the outer surface, both the hydrophilic material and the substrate material are ablated, and therefore the wall of the discharge opening is not covered by the hydrophilic material.

[0175] Figure 12 Showing Figure 11 A further enlarged view shows that the thickness of the hydrophilic material layer 9 decreases toward each inlet opening 5c ​​in the outer surface 8, thereby forming an angled 9a of the coating layer.

[0176] Figure 13 An embodiment of a conduit including protrusions 410 is shown, which surround the inlet opening 5c ​​in the outer surface and extend above the hydrophilic surface 411 of layer 9 when the hydrophilic material constituting layer 9 is not swollen.

[0177] Figure 14 Demonstrates the swelling of hydrophilic materials Figure 13 An example of this embodiment. In this state, the hydrophilic material extends over the protrusion 410.

[0178] Figure 15 The view shows the discharge section of the conduit as seen from above. In this view, discharge openings 5 ​​are shown arranged into groups R1, R2, and R3. Group R1 includes multiple discharge openings arranged along the first row and having non-circular external openings 8a. Group R3 also has non-circular openings. Group R2 includes multiple discharge openings with circular external openings 8a.

[0179] Figure 16A A side view of an embodiment of an intermittent urinary catheter 1 is shown, which has discharge openings positioned in three groups 4a, 4b, and 4c. In the first group 4a, the discharge openings are positioned in a dense configuration; in the second group 4b, the discharge openings are positioned in a less dense configuration; and in the third group 4c, the discharge openings are positioned even further apart.

[0180] Figure 16BA side view of an embodiment of an intermittent urinary catheter with a discharge section 4 is shown, wherein the discharge openings 5 ​​are positioned in three rows. Two rows are visible in the view, but the third row is positioned posteriorly to the catheter and is therefore shown as a dashed line.

[0181] Figure 17 An enlarged schematic diagram of a cross-section of a portion of a conduit along its central axis CA is shown. In this view, the conduit 1 is shown forming a tubular wall 1b that defines an inner surface 6 facing the discharge conduit 7 and an opposite outer surface 8 facing away from the discharge conduit, the outer surface extending continuously from the proximal insertion end to the distal outlet. Both the proximal insertion end and the distal outlet are... Figure 17 Outside the boundary.

[0182] The catheter includes a discharge section intended for insertion into the body. The discharge section includes multiple discharge openings 5. Each discharge opening extends along a corresponding centerline CL from an internal opening 6a into the discharge conduit 7 to an external opening 8a in the outer surface 8. The centerlines of the discharge openings intersect at a point P outside the discharge conduit 7.

[0183] Figure 18 Showing Figure 15 A perspective view of a portion of the emission section. In this view, the centerlines CL of all emission openings intersect at point P.

[0184] Figure 19 Showed along Figure 15 Section AA is a section transverse to the central axis.

[0185] The emission openings form a first group R1, a second group R2, and a third group R3, as relative to... Figure 15 As mentioned and shown, each centerline of the first set of emission openings intersects with at least one centerline of the second set of emission openings at a point P outside the emission duct 7 and significantly above the outer surface 8.

[0186] In an alternative embodiment, for each emission opening in one of groups R1, R2, or R3, consider Figure 19 The cross-section is of the type shown. In this alternative embodiment, the centerline of one group, namely the centerline of R1, R2 or R3, is parallel to the centerline of the same group of discharge openings in other cross-sections, while the centerline of one group of discharge openings still intersects at point P outside the discharge pipe 7 with at least one centerline of the other group of discharge openings.

[0187] Figure 20An enlarged schematic diagram of a section of a conduit along its central axis CA is shown. In this view, the conduit 1 is shown forming a tubular wall 1b that defines an inner surface 6 facing the discharge conduit 7 and an opposite outer surface 8 facing away from the discharge conduit. This outer surface extends from the proximal insertion end to the distal outlet. Both the proximal insertion end and the distal outlet are located at… Figure 20 Outside the boundary.

[0188] The catheter includes a discharge portion intended for insertion into the body. The discharge portion includes multiple discharge openings 5. Each discharge opening extends along a corresponding centerline CL from an internal opening 6a into the discharge conduit 7 to an external opening 8a in the outer surface 8.

[0189] Each discharge opening extends along a corresponding centerline from the inner surface facing the discharge pipe to the outer surface facing away from the discharge pipe, wherein the discharge openings are formed in pairs such that a pair of discharge openings includes a first discharge opening 5' and a second discharge opening 5' having the same centerline. Each pair of discharge openings includes one discharge opening 5' located on one side of the central axis and another discharge opening 5' located on the opposite side of the central axis.

[0190] exist Figure 20 In the embodiment shown, the centerline CL of the discharge opening intersects at point P outside the discharge pipe 7.

[0191] exist Figure 20 In the embodiment shown, the emission openings are shown as converging in the upper half of the figure, meaning that the inlet opening 8a is larger than the outlet opening 6a, while in the lower half the emission openings are shown as diverging, meaning that the outlet opening 6a is larger than the inlet opening 8a.

[0192] Figure 21 An alternative embodiment with a parallel centerline is shown. In the illustrated embodiment, the exhaust opening has a vertical exhaust opening wall; however, it is also conceivable that the exhaust opening walls could be converging and diverging, respectively. Figure 20 As shown.

[0193] Figure 22 Showed along Figure 15 The cross-sectional view of section AA is transverse to the central axis. Each centerline extends through the two exhaust openings 5' and 5'". At least the middle pair of exhaust openings are located on opposite sides of the central axis CA.

[0194] At least one centerline of the first set of discharge openings and the second set of discharge openings intersects at a point P outside the discharge duct 7 and significantly above the outer surface 8. In an alternative embodiment, the centerlines are parallel, as shown below. Figure 21 As shown.

[0195] Figure 23An enlarged schematic diagram of a section of a conduit along its central axis CA is shown. In this view, the conduit 1 is shown forming a tubular wall 1b that defines an inner surface 6 facing the discharge conduit 7 and an opposite outer surface 8 facing away from the discharge conduit. This outer surface extends from the proximal insertion end to the distal outlet. Both the proximal insertion end and the distal outlet are located at… Figure 23 Outside the boundary.

[0196] The catheter includes a first discharge zone intended for insertion into the body. The first discharge zone includes a plurality of discharge openings 5. Each discharge opening extends along a corresponding centerline CL from an internal opening 6a into the discharge conduit 7 to an external opening 8a in the outer surface 8.

[0197] Each exhaust opening extends along a corresponding centerline from an inner surface facing the exhaust pipe to an outer surface facing away from the exhaust pipe, wherein the exhaust openings are formed such that all exhaust openings are displaced relative to each other, so that no exhaust opening is positioned along the centerline of another exhaust opening.

[0198] exist Figure 23 In the illustration, the conduit includes a first set of discharge openings 5' and a second set of discharge openings 5'". The two sets are located on opposite sides of the central axis CA, but they are offset along the direction of the central axis CA, such that no discharge opening is located at the centerline of the other discharge opening.

[0199] exist Figure 23 In the embodiment shown, the centerlines of the discharge openings intersect at point P outside the discharge pipe 7.

[0200] Figure 24 An alternative embodiment with parallel centerlines is shown.

[0201] Figure 25 Showing with Figure 22 The view in the diagram is similar to a cross-sectional view, but it is based on, for example... Figure 24 The conduit section is shown. Each centerline extends only through one discharge opening 5' or 5', and never through two discharge openings.

[0202] The discharge opening 5' intersects with the discharge pipe 7 at point P outside the pipe.

[0203] Figures 5 to 25 The common feature of all the above embodiments shown is that the discharge opening can be efficiently created by laser ablation (e.g., by a laser arranged at point P).

[0204] Figure 26This diagram schematically illustrates the pressure pulses that occur in an intermittent catheter during bladder emptying. The figure shows the pressure differential changing over time during a series of obstructions at the drain opening in the catheter. The pressure pulses occur as a sudden drop in pressure over a very short period (approximately 100 milliseconds or less), shown as a peak on the curve in the figure. As explained above, the pressure pulses occur because the movement of urine through the catheter abruptly stops due to tissue obstruction of the drain opening.

[0205] Figures 26 to 31 Demonstrated by using Figures 32-34 The test device in the middle is used to test various catheters and obtain the results. Figure 26 Results from tests on male catheters were presented with a discharge height of 15-20 cm and a water level of 10 cm H2O. Figure 26 Starting on the left, this graph shows the pressure pulses obtained within a prior art conduit of size CH16, which has two regular discharge openings with a maximum size of 5.6 mm. One of the discharge openings was closed before testing. Figure 26 As can be seen, the pressure pulse exceeds 200 mBar. Moving to the right of the graph, the next graph shows the pressure pulse obtained in a prior art catheter of size CH 12, which has two discharge openings with a maximum size of 3.9 mm. Such a catheter provides a pressure pulse of approximately 200 mBar. The third graph from the left shows the pressure pulse obtained on a prior art catheter of size CH10, which has a discharge opening with a maximum size of 3.4 mm. Here, the pressure pulse exceeds 100 mBar. The fourth graph from the left shows the pressure pulse obtained on an intermittent catheter as described herein, which has an open discharge opening with a maximum size of 1 mm. This graph shows that the pressure pulse only reaches about 40 mBar. The rightmost graph shows the pressure pulse of an intermittent catheter as described herein, which has an open discharge opening with a maximum size of approximately 0.4 mm. Here, the pressure is almost non-existent—the curve shows almost no peaks.

[0206] Figure 27 Results from tests on male catheters were presented with a discharge height of 25 cm and a water level of 50 cm H2O. Figure 27Starting from the left side, the graph shows the pressure pulses obtained in catheters with a single open discharge opening, which increases in size from left to right. The results are also reported in Table 2 below. It can be seen that for a discharge opening with a maximum size of 4 mm, the pressure pulse (under these test conditions) reaches 652 mBar, while towards the left, when the discharge opening is 0.19 mm, the pressure pulse (under these test conditions) is as low as 15 mBar. Levels of less than 100 mBar are obtained with discharge openings less than approximately 0.4 mm, less than 200 mBar with discharge openings less than approximately 0.6 mm, and less than 350 mBar with discharge openings less than approximately 1.00 mm.

[0207] Figure 28 Results from tests on female catheters were presented with a discharge height of 6 cm and a water level of 50 cm H2O. Figure 28 Starting on the left, the graph shows the pressure pulses obtained in catheters with a single open discharge opening, which increases in size from left to right. The results are also reported in Table 3 above. It can be seen that for a discharge opening with a maximum size of 4 mm, the pressure pulse (under these test conditions) reaches 639 mBar, while towards the left, when the discharge opening is 0.19 mm, the pressure pulse (under these test conditions) is as low as 12 mBar. Levels of less than 100 mBar are obtained with discharge openings less than approximately 0.5 mm, less than 200 mBar with discharge openings less than approximately 0.7 mm, and less than 350 mBar with discharge openings less than approximately 1.00 mm.

[0208] Figure 29A and Figure 29B Showing according to Figure 32 The test results are obtained from the tests performed by the testing equipment in the test. Figure 29BThe correlation between the amount of bladder wall or urethral tissue entering the lumen through the discharge opening, the size of the discharge opening, and the measured pressure pulse is shown at a relatively large scale. Based on the test results, it should be understood that pressure pulses below 40 mBar reduce the risk of bladder wall or urethral tissue entering the lumen through the small discharge opening in the intermittent catheter, and reduce the risk of tissue impact. In the embodiments disclosed herein, an intermittent catheter is implemented in which, when the pressure pulse is below 40 mBar, no or very little tissue enters the lumen through the small discharge opening. Pressure pulses below 40 mBar are obtained when the maximum size of the discharge opening is less than 0.7 mm. Therefore, the embodiments relate to intermittent catheters constructed to provide pressure pulses below 40 mBar. A relevant embodiment is an intermittent catheter having a discharge opening with a maximum size of less than 0.7 mm.

[0209] Figure 30 and Figure 31 Showing according to Figure 33 and Figure 34 The test results are obtained from the tests performed by the testing equipment in the test. Figure 30 The results are used for testing, such as Figure 33 The male catheter shown, and Figure 31 The results are used for testing, such as Figure 34 The results for the female catheter are shown. The difference is that for the male catheter, the height difference between the discharge opening and the catheter exit level is 25 cm, while for the female catheter, the height difference is 6 cm.

[0210] exist Figure 30 and Figure 31 The results of tests on discharge openings with a maximum size of 1 mm and below are shown. These curves illustrate that with a discharge opening smaller than 1 mm, the pressure pulse will be below 350 mBar for male catheters and below 300 mBar for female catheters. With a discharge opening of 0.8 mm, the pressure pulse will be approximately 260 mBar for males and approximately 210 mBar for females. With a discharge opening of 0.4 mm, the pressure pulse will be approximately 90 mBar for male catheters and approximately 75 mBar for female catheters.

[0211] Example

[0212] In the following text, non-limiting examples of embodiments, methods of use, and methods of manufacture of intermittent hydrophilic catheters will be mentioned.

[0213] 1. An intermittent hydrophilic catheter defining a discharge conduit extending longitudinally from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a tube having a tubular wall made of a base material and defining an inner surface facing the discharge conduit and an opposite outer surface facing away from the discharge conduit, wherein at least an insertable portion of the outer surface is covered by a layer of hydrophilic material configured to change from a non-swellable state to a swellable state by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the catheter on the outer surface by a coating thickness, and wherein the catheter includes a plurality of discharge openings, each discharge opening being defined by a discharge opening wall extending between an outlet opening in the inner surface and an inlet opening in the outer surface, wherein the discharge opening wall is not covered by the hydrophilic material.

[0214] 2. The conduit according to Embodiment 1, wherein the discharge opening is made by laser ablation of the hydrophilic material and the substrate material, thereby ensuring that the wall of the discharge opening is not covered by the hydrophilic material.

[0215] 3. The conduit according to embodiment 1 or 2, wherein the discharge opening wall has a height corresponding to the distance between the inner surface and the outer surface.

[0216] 4. The catheter according to any of the foregoing embodiments, wherein the outer surface extends continuously from the proximal insertion end to the distal outlet end.

[0217] 5. The conduit according to any of the foregoing embodiments, wherein the coating thickness decreases toward each inlet opening in the outer surface.

[0218] 6. The conduit according to any of the foregoing embodiments, wherein the tubular wall of the conduit has a uniform wall thickness.

[0219] 7. The conduit according to any of the foregoing embodiments, wherein the conduit has a uniform outer surface.

[0220] 8. The conduit according to any of the foregoing embodiments, the conduit including a protrusion surrounding an inlet opening in the outer surface and extending above the hydrophilic surface when the hydrophilic material is in the non-swelling state.

[0221] 9. The catheter according to Example 8, wherein when the hydrophilic material is in the swollen state, the hydrophilic material extends over the protrusion.

[0222] 10. The catheter as described in any of the foregoing embodiments, wherein the discharge opening has a diameter of less than 0.4 mm. 2 The cross-sectional area.

[0223] 11. The catheter according to any of the foregoing embodiments, wherein the proximal insertion end forms a closed end.

[0224] 12. The catheter according to embodiment 11, the catheter being defined as a non-discharge portion distal to the tip and a discharge portion distal to the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

[0225] 13. The conduit according to any of the foregoing embodiments, wherein the sum of the cross-sectional areas of the discharge openings is greater than the cross-sectional area of ​​the discharge pipe.

[0226] 14. A method of manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube made of a base material, the tube defining a tubular shape having an inner surface facing a discharge conduit and an opposite outer surface facing away from the discharge conduit; coating the outer surface with a hydrophilic material to define a hydrophilic surface; and providing a plurality of discharge openings from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that the walls of the discharge openings extending between the inner surface and the outer surface are not coated.

[0227] 15. The method according to Example 13, wherein the tube is provided by extruding the base material via a die.

[0228] 16. A method for reducing local suction peak pressure in the bladder's discharge opening due to obstruction of the discharge opening by using an intermittent catheter as described in any one of Examples 1-12.

[0229] 17. An intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter including a plurality of discharge openings, each discharge opening extending along a corresponding central line from an internal opening into the discharge conduit to an external opening in an outer surface, wherein at least two discharge openings have central lines intersecting at an intersection outside the discharge conduit.

[0230] 18. The conduit according to Example 17, wherein the centerlines of all discharge openings intersect at the intersection.

[0231] 19. The catheter according to Embodiment 17, the catheter comprising a first set of discharge openings and a second set of discharge openings, the centerlines of the first set of discharge openings being parallel, the centerlines of the second set of discharge openings being parallel, and each centerline of the first set of discharge openings intersecting at least one centerline of the second set of discharge openings at the intersection point.

[0232] 20. The catheter according to any one of embodiments 17 to 19, wherein the intersecting center lines extend from the intersection point at an angle of 1-4 degrees.

[0233] 21. The catheter according to any one of embodiments 17-20, wherein the distance between the intersection and the outer surface corresponds to at least 10 times the distance from the outer surface to the central axis.

[0234] 22. The catheter according to any one of embodiments 17 to 21, wherein the first set of external openings is non-circular and the second set of external openings is circular.

[0235] 23. The catheter according to embodiment 22, wherein the opening in the first set of external openings extends along a first external straight line parallel to the central axis.

[0236] 24. The catheter according to embodiment 22 or 23, wherein the opening in the second set of external openings extends along a second external straight line parallel to the central axis.

[0237] 25. The conduit according to any one of Examples 17 to 24, wherein the discharge opening has a cross-sectional area of ​​less than 0.4 mm².

[0238] 26. The catheter according to any one of embodiments 17 to 25, wherein the proximal insertion end forms a closed end.

[0239] 27. The catheter according to embodiment 26, wherein the catheter is defined as a non-discharge portion distal to the tip and a discharge portion distal to the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

[0240] 28. The conduit according to any one of embodiments 17 to 27, wherein the sum of the cross-sectional areas of the discharge openings is greater than the cross-sectional area of ​​the discharge pipe.

[0241] 29. A method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a tubular shape having an inner surface facing an internal discharge conduit and an opposite outer surface facing away from the internal discharge conduit; and providing a plurality of discharge openings extending between an inner opening in the inner surface and an outer opening in the outer surface by laser ablation of the base material, wherein the laser ablation is performed using a laser emitted from an emitter point outside the discharge conduit at a certain emission angle, such that a first set of discharge openings is provided with a first emission angle and a second set of discharge openings is provided with a second emission angle.

[0242] 30. The method according to embodiment 29, wherein the discharge openings are configured in pairs, one discharge opening from the first set of discharge openings and one discharge opening from the second set of discharge openings, and wherein the emitter point moves relative to the tube between each pair of discharge openings.

[0243] 31. The method according to embodiment 29 or 30, wherein the distance from the emitter point to the outer surface remains constant when the discharge opening is provided.

[0244] 32. The method according to any one of embodiments 29 to 31, wherein the discharge opening is provided by ablation, while the pressure in the discharge pipe changes relative to the pressure outside the discharge pipe.

[0245] 33. The method according to any one of Examples 29 to 32, wherein the outer surface is coated with a hydrophilic material before the discharge opening is provided.

[0246] 34. A method for reducing local suction peak pressure in the bladder's discharge opening due to obstruction of the discharge opening by using an intermittent catheter as described in any one of Examples 17 to 28.

[0247] 35. An intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter including a plurality of discharge openings, each discharge opening extending along a corresponding central line from an inner surface toward the discharge conduit to an outer surface away from the discharge conduit, wherein the discharge openings are formed in pairs such that a pair of discharge openings includes a first discharge opening and a second discharge opening having the same central line.

[0248] 36. The catheter according to embodiment 35, wherein the first discharge opening and the second discharge opening are located on opposite sides of the central axis.

[0249] 37. The conduit according to embodiment 35 or 36, wherein each discharge opening is defined by a wall extending from an inner surface toward the discharge conduit to an outer surface away from the discharge conduit, wherein the wall of the first discharge opening converges in a direction from the outer surface to the inner surface, and the wall of the second discharge opening diverges in a direction from the outer surface to the inner surface.

[0250] 38. The catheter according to any of the foregoing embodiments 35 to 37, wherein the first discharge opening and the second discharge opening have different sizes.

[0251] 39. The catheter according to any one of embodiments 35 to 38, wherein the discharge opening has a diameter of less than 0.4 mm. 2 The cross-sectional area.

[0252] 40. The catheter according to any one of embodiments 35 to 39, wherein the proximal insertion end forms a closed end.

[0253] 41. The catheter according to embodiment 40, wherein the catheter is defined as a non-discharge portion distal to the tip and a discharge portion distal to the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

[0254] 42. The conduit according to any one of embodiments 35 to 41, wherein the sum of the cross-sectional areas of the discharge openings is greater than the cross-sectional area of ​​the discharge pipe.

[0255] 43. A method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit; and providing a plurality of discharge openings extending between an internal opening in an inner surface facing the discharge conduit and an external opening in an outer surface facing away from the discharge conduit, the discharge openings being formed by laser ablation of the base material, wherein the laser ablation is performed to form a pair of discharge openings including a first discharge opening and a second discharge opening, provided by simultaneously ablating the base material along a common centerline on opposite sides of the central axis.

[0256] 44. The method according to embodiment 43, wherein the laser is emitted from an emitter point outside the discharge duct through the internal discharge duct.

[0257] 45. The method according to embodiment 43 or 44, wherein the laser is emitted in the form of at least two subsequent pulses.

[0258] 46. ​​The method according to any one of embodiments 43 to 45, wherein the aperture size of at least one of the first discharge opening and the second discharge opening is determined, and wherein the laser ablation is performed with a number of emission determined by the aperture size.

[0259] 47. A method for reducing local suction peak pressure in the bladder's discharge opening due to obstruction of the discharge opening by using an intermittent catheter as described in any one of Examples 35 to 42.

Claims

1. A method of manufacturing an intermittent urinary catheter, the method comprising: A tube made of a base material is provided, the tube defining a tubular shape having an inner surface facing an internal discharge pipe and an opposite outer surface facing away from the internal discharge pipe; The catheter is provided by laser ablation of the substrate material to provide a plurality of discharge openings extending between an internal opening in the inner surface and an external opening in the outer surface, wherein the laser ablation is performed using a laser emitted from a single emitter point outside the internal discharge conduit at a certain emission angle, such that a first set of discharge openings is provided with a first emission angle and a second set of discharge openings is provided with a second emission angle, wherein the laser ablation is performed to form a pair of discharge openings including a first discharge opening and a second discharge opening, provided by simultaneously ablating the substrate material along a common center line on opposite sides of the central axis of the internal discharge conduit, and wherein the catheter is formed to have at least 12 discharge openings.

2. The method of claim 1, wherein, The emission openings are configured in pairs, one from the first set of emission openings and one from the second set of emission openings, wherein the individual emitter point moves relative to the tube between each pair of emission openings.

3. The method of claim 1 or 2, wherein, When providing the emission opening, the distance from the single emitter point to the outer surface remains constant.

4. The method of claim 1 or 2, wherein, While the discharge opening is provided by ablation, the pressure in the internal discharge pipe changes relative to the pressure outside the internal discharge pipe.

5. The method of claim 1 or 2, wherein, Before providing the discharge opening, the outer surface is coated with a hydrophilic material.

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